alvimopan

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alvimopan

(al-vi-mo-pan) ,

Entereg

(trade name)

Classification

Therapeutic: gastric stimulant
Pharmacologic: opioid antagonists
Pregnancy Category: B

Indications

Speed time to upper/lower GI recovery following partial bowel resection surgery with primary anastamosis.

Action

Acts peripherally as μ-opioid receptor antagonist which speeds recovery of bowel function after to partial large or small bowel resection surgery with anastomosis surgery.

Therapeutic effects

Accelerated time to bowel recovery following primary anastamotic surgery.

Pharmacokinetics

Absorption: 6% absorbed following oral administration.
Distribution: Does not cross the blood-brain barrier.
Protein Binding: alvimopan—80% bound to albumin; metabolite—94% bound to albumin.
Metabolism and Excretion: Converted by bacterial flora in the GI tract to an active metabolite; elimination is mostly via biliary secretion, followed by conversion by bacterial flora. Elimination of unabsorbed drug and metabolites is via feces and urine.
Half-life: alvimopan—10–17 hr; metabolite—10–18 hr.

Time/action profile (blood leves)

ROUTEONSETPEAKDURATION
POunknown2 hr12 hr

Contraindications/Precautions

Contraindicated in: Therapeutic doses of opioid analgesics for more than 7 consecutive days before initiation of alvimopan; Severe hepatic impairment or end-stage renal disease.
Use Cautiously in: More than 3 doses of opioids within the wk prior to surgery (↑ sensitivity to effects and adverse reactions including abdominal pain, nausea, vomiting and diarrhea); Mild to moderate hepatic or renal impairment (↑ risk of adverse reactions); genetic implication Japanese patients (may have ↑ risk of adverse reactions); Geriatric: May have ↑ sensitivity to effects; Obstetric / Lactation: Use in pregnancy only if clearly needed; use cautiously during lactation; Pediatric: Safety not established.

Adverse Reactions/Side Effects

Cardiovascular

  • MI (life-threatening)

Gastrointestinal

  • constipation (most frequent)
  • dyspepsia (most frequent)
  • flatulence (most frequent)

Fluid and Electrolyte

  • hypokalemia

Genitourinary

  • urinary retention

Hematologic

  • anemia

Musculoskeletal

  • back pain

Interactions

Drug-Drug interaction

Previous (within 1 wk) opioid use ↑ risk of adverse reactions (avoid if therapeutic opioid doses used during prior wk, use cautiously if more than 3 doses have been used).

Route/Dosage

Oral (Adults) 12 mg for 30 min–5 hr prior to surgery, then 12 mg twice daily for up to 15 doses.

Availability

Capsules: 12 mg

Nursing implications

Nursing assessment

  • Assess bowel sounds and frequency, quantity, and consistency of stools periodically during therapy.
  • Lab Test Considerations: May cause anemia and hypokalemia.

Potential Nursing Diagnoses

Constipation (Indications)

Implementation

  • Must be administered only during hospitalization. Only available in hospitals enrolled in the Entereg Access Support and Education (E.A.S.E.) program.
  • Oral: Administer twice daily without regard to food for no more than 7 days.

Patient/Family Teaching

  • Explain purpose of alvimopan to patient.
  • Advise patient to notify health care professional if they have taken long term or intermittent opioid pain therapy, including any use of opioids in the wk prior to receiving alvimopan.

Evaluation/Desired Outcomes

  • Resolution of postoperative ileus following bowel resection.
References in periodicals archive ?
These may include statements regarding market prospects for ENTEREG, including whether growth in net product sales will continue; anticipated scientific progress on Adolor's research programs; development of potential pharmaceutical products, including the OIC program and the timing and results of any clinical studies of Adolor's compounds; interpretation of clinical results; prospects for regulatory approvals; and other statements regarding matters that are not historical facts.
The FDA accepted the Entereg NDA for review in September, which triggered the receipt of a $10.
Currently, ENTEREG is co-promoted by Adolor and GSK in the United States.
A poster1 reporting the evaluation of ENTEREG use in clinical practice using a large in-patient database will be presented.
These may include statements regarding market prospects for ENTEREG, including whether growth in net product sales will continue or physician interest in the product will grow; anticipated scientific progress on Adolor's research programs; development of potential pharmaceutical products, including the OIC program and the timing and results of any clinical studies of Adolor's compounds; interpretation of clinical results; prospects for regulatory approvals; and other statements regarding matters that are not historical facts.
Cubist Pharmaceuticals' supplemental new drug application (sNDA) Entereg (alvimopan) is approved by the US Food and Drug Administration (FDA.
The increase in net sales was driven primarily by an increase in the number of hospitals ordering ENTEREG and increased penetration within existing hospital customers, as well as the impact of pricing changes since the first quarter of 2010.
ENTEREG is available for short-term use in hospitals registered under the Entereg Access Support and Education (E.
The agency approved a seven-day regimen of the medicine, Entereg, for hospital patients with a condition known as post-operative ileus.
Adolor and GlaxoSmithKline are collaborating in the worldwide development and commercialization of Entereg in multiple indications.
GlaxoSmithKline revealed that it had gained backing from Food and Drug Administration (FDA) for Entereg.
Patients Report Statistically Significant Improvement in Opioid-Induced Gastrointestinal Side Effects and Health-Related Quality of Life in Phase 2b Entereg Trial